Dong-A ST Neurobo Begins Global Phase 2 Dosing of NASH Treatment 'DA-1241'

Dong-A ST Subsidiary Neurobo Pharmaceuticals
First New Drug in GPR119 Mechanism Series
Targeting Completion in Second Half of 2024

Neurobo Pharmaceuticals, a subsidiary of Dong-A ST, announced on the 18th that it has started dosing the first patient in the United States for the global Phase 2 clinical trial of the non-alcoholic steatohepatitis (NASH) treatment 'DA-1241.'

Logos of Dong-A ST (top) and Neurobo Pharmaceuticals.
[Photo by each company]

Neurobo Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical trial of DA-1241 in May. In August, it obtained Institutional Review Board (IRB) approval in the U.S., completed screening of clinical trial subjects, and registered the first clinical patient. The first patient dosing was conducted on the 14th at a designated clinical trial site in the United States.

This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel comparison study involving 86 NASH patients over 16 weeks to verify the efficacy and safety of DA-1241.

DA-1241 is the first-in-class drug with a GPR119 agonist mechanism, and the company explained that its potential as a NASH treatment was confirmed in preclinical studies. Specifically, improvements were observed in liver cirrhosis, inflammation, fibrosis, lipid metabolism, and glucose regulation after administration of DA-1241.

Neurobo Pharmaceuticals plans to complete the global Phase 2 clinical trial of DA-1241 in the second half of 2024.

Neurobo Pharmaceuticals, listed on NASDAQ and located in Boston, USA, serves as the global research and development (R&D) hub of the Dong-A Socio Group, responsible for the global development and commercialization of DA-1241 and DA-1726. DA-1726, being developed as a treatment for obesity and NASH, is expected to submit an Investigational New Drug (IND) application for a global Phase 1 clinical trial in the second half of this year.

A representative of Neurobo Pharmaceuticals stated, "With the dosing of the first patient in the global Phase 2 clinical trial of DA-1241, the clinical trial has officially begun. We will do our best to successfully complete the global Phase 2 trial to secure the title of the first NASH treatment."

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